Label: TARGET ANTIFUNGAL- tolnaftate cream

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated June 23, 2023

If you are a consumer or patient please visit this version.

View All Sections
  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

    Tolnaftate 1%

  • Purpose

    Antifungal

  • Uses

    • proven clinically effective in the treatment of most athlete's foot (tinea pedis) and ringworm (tinea corporis)
    • helps prevent most athlete's foot with daily use
    • for effective relief of itching, burning and cracking
  • Warnings

    For external use only

    When using this product avoid contact with eyes

    Stop use and ask a doctor if

    • irritation occurs
    • there is no improvement within 4 weeks

    Do not use on children under 2 years of age except under the advice and supervision of a doctor.

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    • wash affected area and dry thoroughly
    • apply a thin layer over affected area twice daily (morning and night)
    • supervise children in the use of this product
    • for athlete's foot: pay special attention to spaces between the toes; wear well-fitting, ventilated shoes and change shoes and socks at least once daily
    • use daily for 4 weeks; if condition persists longer, ask a doctor
    • to prevent athlete's foot, apply once or twice daily (morning and/or night)
    • this product is not effective on the scalp or nails
  • Other information

    • store between 20° to 25°C (68° to 77°F)
    • see carton or tube crimp for lot number and expiration date
  • Inactive ingredients

    BHT, PEG-400, PEG-3350, titanium dioxide, white petrolatum

  • Questions?

    Call 1-800-910-6874

  • SPL UNCLASSIFIED SECTION

    Distributed by Target Corporation
    Minneapolis, MN 55403

  • PRINCIPAL DISPLAY PANEL - 30 g Tube Carton

    up&up

    antifungal cream
    tolnaftate 1%

    cures and prevents most athlete's foot and ringworm
    helps relieve itching and burning

    NET WT 1 OZ (30 g)

    PRINCIPAL DISPLAY PANEL - 30 g Tube Carton
  • INGREDIENTS AND APPEARANCE
    TARGET   ANTIFUNGAL
    tolnaftate cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11673-912
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Tolnaftate (UNII: 06KB629TKV) (Tolnaftate - UNII:06KB629TKV) Tolnaftate10 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    Butylated Hydroxytoluene (UNII: 1P9D0Z171K)  
    Polyethylene Glycol 400 (UNII: B697894SGQ)  
    Polyethylene Glycol 3350 (UNII: G2M7P15E5P)  
    Titanium Dioxide (UNII: 15FIX9V2JP)  
    Petrolatum (UNII: 4T6H12BN9U)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:11673-912-021 in 1 CARTON02/17/2006
    128.3 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart333C02/17/2006
    Labeler - Target Corporation (006961700)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!